Events

Recall of Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical PM, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38472
  • Event Risk Class
    Class 3
  • Event Number
    Z-1240-2007
  • Event Initiated Date
    2007-07-18
  • Event Date Posted
    2007-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53824
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Monitor - Product Code DQA
  • Reason
    Phantom pacer spikes caused by a damaged resistor.
  • Action
    Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.

Device

Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor
  • Model / Serial
    Catalog number/ serial number: 3404001/AI05110052/ AI05120000/ AI05120011/ AI05120012/ AI05120013/ AI05120018/ AI06060015/ AI06070047/ AI06100004/ AI06100005/ AI06100006/ , 3404001S/AI05110000/ AI05110001/ AI05110002/ AI05110003/ AI05110004/ AI05110005/ AI05110006/ AI05110007/ AI05110008/ AI05110009/ AI05110010/ AI05110011/ AI05110012/ AI05110013/ AI05110014/ AI05110015/ AI05110016/ AI05110017/ AI05110018/ AI05110019/ AI05110020/ AI05110021/ AI05110022/ AI05110023/ AI05110024/ AI05110025/ AI05110026/ AI05110027/ AI05110028/ AI05110029/ AI05110030/ AI05110031/ AI05110032/ AI05110033/ AI05110034/ AI05110035/ AI05110036/ AI05110037/ AI05110038/ AI05110039/ AI05120010/ AI05120016/ AI05120017/ AI05120019/ AI06010042/ AI06010043/ AI06060003/ AI06060004/ AI06060005/ AI06060006/ AI06060007/ AI06060008/ AI06060009/ AI06060010/ AI06060011/ , 3404002/AI05090021/ AI05090024/ AI05110049/ AI05120015/ AI06010035/ AI06010036/ AI06010049/ AI06040000/ AI06040001/ AI06040002/ AI06040003/ AI06040004/ AI06040005/ AI06040006/ AI06040007/ AI06040008/ AI06040009/ AI06040010/ AI06040011/ AI06040012/ AI06040013/ AI06040014/ AI06040015/ AI06040016/ AI06040017/ AI06040018/ AI06040020/ AI06060012/ AI06060013/ AI06060014/ AI06060017/ AI06060018/ AI06060019/ AI06060020/ AI06070037/ AI06070038/ AI06070039/ AI06070040/ AI06070042/ AI06070043/ AI06070044/ AI06070045/ AI06090053/ AI06100011/ AI06100012/ AI07010057/ AI07010058/ , 3404002E/AI05110040 AI05110041/ AI05110042/ AI05120001/ AI05120002/ AI05120005/ AI05120006/ AI05120007/ AI05120008/ AI05120009/ AI05120024/ AI06010041/ AI06010044/ AI06010045/ AI06010046/ AI06010048/ AI06040019/ AI06040023/ AI06040024/ AI06070041/ AI06070046/ AI06070048/ AI06070049/ AI06090050/ AI06090051/ , 3404002F/AI07010067/ AI07010068/ , 3404002G/AI05110050/ AI05110051/ AI05120003/ AI05120004/ AI06060021/ AI06060022/ AI06060023/ AI06070035/ AI06070036/ AI06090054/ AI06090055/ AI06090056/ AI06090057/ AI06090058/ AI06100008/ AI06100009/ AI06100010/ AI06100018/ , 3404002S/AI05110043/ AI05110044/ AI05110045/ AI06010037/ AI06010038/ AI06010039/ AI06010040/ AI06060000/ AI06060001/ AI06060002/ AI06060016/ AI06090052/ AI06100019/ AI06100020/ AI06100021/ AI06100022/ AI06100023/ AI06100024/ AI07010050/ AI07010051/
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.
  • Product Description
    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Manufacturer Address
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA